HEP102 - DHELIVER

• Research type

  Research Study

• Full title

  Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER

• IRAS ID

  276479

• Contact name

  Etienne Sokal

• Contact email

  Regulatory@promethera.com

• Sponsor organisation

  Promethera Therapeutics

• Eudract number

  2019-003051-11

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 30 months, 0 days

• Research summary

  This is a randomized, multi-centre Phase IIb study to evaluate the safety and efficacy of HepaStem compared to placebo in patients with a cirrhotic liver condition called Acute on Chronic Liver Failure (ACLF). The study will be performed in multiple centers and in a double-blinded manner, meaning neither the patients nor the treating physicians know who is on placebo or the study drug.
  This study will be conducted in approximately 80 hospital centres in at least 20 European countries (3 sites in the UK) .
  After the completion of the study, the patients who received at least one
  infusion with HepaStem will be proposed to enter a long-term safety follow-up
  study named PROLONGSTEM for 5 additional years.

• REC name

  North East - York Research Ethics Committee

• REC reference

  20/NE/0086

• Date of REC Opinion

  30 Jun 2020

• REC opinion

  Further Information Favourable Opinion